Diabetes in Pregnancy and Pregnancy Outcomes

July 18, 2018 updated by: Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University

Diabetes in Pregnancy, Therapy and Pregnancy Outcomes

To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus.

This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.

Study Type

Observational

Enrollment (Actual)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24.

Description

Inclusion Criteria:

  • Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
  • Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester

Exclusion Criteria:

  • Pregnancy is still undergoing
  • Incomplete record of glycemic profile, management and fetal outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
Dietary supplement: Medical Nutrition Therapy
Only given medical nutrition therapy.
Drug: Insulin
Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
Drug: Oral Antidiabetics
Prescribed with all types of oral anti-diabetics.
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
Dietary supplement: Medical Nutrition Therapy
Only given medical nutrition therapy.
Drug: Insulin
Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
Drug: Oral Antidiabetics
Prescribed with all types of oral anti-diabetics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Mortality
Time Frame: Throughout the length of pregnancy, an average of 9 months
Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Gestational Age at Birth
Time Frame: At time of delivery
Infant Gestational at Birth as recorded in medical records
At time of delivery
Infant Body Weight
Time Frame: At time of delivery
Infant Body Weight as recorded in medical records
At time of delivery
Infant Body Length
Time Frame: At time of delivery
Infant Body Length as recorded in medical records
At time of delivery
Infant Head Circumference
Time Frame: At time of delivery
Infant Head Circumference as recorded in medical records
At time of delivery
APGAR Score
Time Frame: At time of delivery
One and five minute APGAR Scores as recorded in medical records
At time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Mortality
Time Frame: Throughout the length of pregnancy, an average of 9 months
Maternal death as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Comorbidities
Time Frame: Throughout the length of pregnancy, an average of 9 months
Comorbid conditions were defined as either concomitant hypertension, anemia, urinary tract infection, preeclampsia/eclampsia, or combinations of them as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Method of Delivery
Time Frame: At time of delivery
Vaginal Birth or Caesarean Section as recorded in medical records
At time of delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Random Plasma Glucose
Time Frame: Throughout the length of pregnancy, an average of 9 months
Random Plasma Glucose levels as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Fasting Plasma Glucose
Time Frame: Throughout the length of pregnancy, an average of 9 months
Fasting Plasma Glucose levels as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Oral Glucose Tolerance Test
Time Frame: Throughout the length of pregnancy, an average of 9 months
Oral Glucose Tolerance Test levels as recorded in medical records
Throughout the length of pregnancy, an average of 9 months
Glycated Hemoglobin (HbA1c)
Time Frame: Throughout the length of pregnancy, an average of 9 months
Glycated Hemoglobin (HbA1c) levels as recorded in medical records
Throughout the length of pregnancy, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Tarumanagara University

Collaborators

Hermina Podomoro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (ACTUAL)

July 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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